Job Description

We are hiring in our Diagnostics Regulatory Affairs team based out of our San Diego or Marlborough campus, and are looking for a Regulatory Affairs Manager, responsible for on-market regulatory activities associated with US FDA, EU Notified Body, and other international regulatory agencies.This position is focused on in vitro diagnostic systems including assay, software and hardware. The position requires a person with commitment to excellence, and the ability to work in a fast-paced, technically skilled, team setting.

This is a hybrid role with 2 days onsite per week.

Job Summary

• The primary responsibility of the Manager of Regulatory Affairs is to submit global regulatory submissions for new commercial products, assess product or process changes, and participate in quality related activities (complaints, nonconformances, field actions, etc.) focused on in vitro diagnostic systems, including software and hardware; to meet project timelines and / or regulatory obligations.
• Work cross functionally to assess regulatory impact of fielded product issues with an emphasis on software or hardware. This individual will have the necessary skills and experience to assess potential global field actions, complaints, Post Market Surveillance activities and nonconforming events to comply with applicable regulations. This includes assessing software and hardware changes required for PMA products to meet project timelines and / or regulatory obligations. Includes working with both internal Hologic employees as well as external distributors and affiliates to accomplish the goals in a timely manner.
• Responsible for implementing policies and procedures to accomplish assignments and resolve a broad range of issues. Responsible for ensuring employee compliance with such policies, practices and procedures and for encouraging continuous process improvement. Ensures that the quality of services meets internal and external customer requirements.

Essential Duties and Responsibilities

• Manage staff in implementing regulatory strategy and preparing domestic and international regulatory submissions, focused on software and hardware for in vitro diagnostic systems, to meet organizational goals.
• Participates in product development core teams as regulatory representative, as assigned.
• Provides guidance on regulatory requirements and strategies for issues related product in the field and products still under Hologic’s control with a focus on hardware and software for the IVDR systems. Responsibilities include relevant tasks within the following workflows : Complaints associated with multiple manufacturing sites and respective their respective QMS Vigilance and MDR reporting, as needed Post Market Surveillance Nonconforming product impact assessments Corrective and Field actions
• Manages the preparation of submissions for products to regulatory agencies, and interfaces with agencies to obtain timely approval.
• Provide recommendations on labeling, manufacturing, and analytical and clinical study plans for regulatory compliance
• Maintains advanced working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues, primarily focused on software, including cybersecurity, or hardware that may impact company operations and decision-making; communicates such knowledge to all internal stakeholders.
• Consults with and provides advice to senior management on strategies and plans for regulatory product approvals and on-market regulatory strategies.
• Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
• Resolves and / or facilitates resolution of problems including identifying causes to prevent re- occurrence.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
• Encourages continuous process or procedural improvement.

Required Qualifications and Experience

• Bachelor's Degree required in the life sciences or biomedical engineering with a minimum of 8-10 years direct experience in Regulatory Affairs within the IVD or medical device industries.
• Master’s Degree in biomedical engineering and / or RAC preferred with a minimum of 5-8 years direct experience in Regulatory Affairs within the IVD or medical device industries.
• Software / instrumentation experience strongly preferred.
• Point of care IVD experience preferred

Other Related Skills :

• Must havehighlyeffectiveorganizationalandplanningskillsto applydaily inamultidisciplinary environment.
• Must be able to work effectively in a strongly matrixed team-oriented structure using excellent communication, interpersonal and relationship management skills to successfully interact with Clinical,ResearchandDevelopment,Manufacturing,Quality,Marketing,Operations)and corporate partner counterparts on complex projects.
• Solidworkingknowledgeofglobalregulatoryrequirementsrelatedtomedicaldevices, and preferably in-vitro diagnostics systems, laboratory automation and software / hardware components of IVD medical devices.
• Abilitytoread,analyzeandinterpretcomplex dataandreviewtechnicaldocuments.
• Experience with International submissions and IVDs highly desirable
• Excellent writtenand oralcommunicationskillsandhigh levelof comfortandexperiencepresenting to executive leaders and regulatory agencies.

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

From a benefits perspective, you will have a access to benefits such as medical and dental insurance, ESPP, 401(k) plan, vacation, sick leave and holidays, parental leave, wellness program and many more!

The annualized base salary range for this role is $111,400 to $190,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency and Third-Party Recruiter Notice :

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

LI-RF1 #manager-level

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Regulatory Manager • San Diego, CA, United States

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